1. Field of Invention
The present invention relates generally to the field of orthotic devices and appliances; more particularly to orthotic devices and appliances in combination with electrotherapy useful for restoring movement to a connective joint of a mammalian body; and still more particularly to orthotic devices and appliances in combination with electrotherapy used to reverse contractures due to immobility and neurological dysfunction.
2. Background Discussion
Webster's New Collegiate Dictionary defines "orthotics" as "a branch of mechanical and medical science that deals with the support and bracing of weak or ineffective joints or muscles."
Orthotic devices and appliances, commonly referred to just as "orthotics" (in spite of the broader dictionary definition of orthotics) have been utilized for many years by physical therapists, occupational therapists, and certified orthotic fitters to assist in the rehabilitation of loss of range of motion (LROM) of patients' joints and associated limbs or adjacent skeletal parts of the patients' body.
Orthotics, as well as splints, have been designed both to maintain and to restore the range of bodily motion due to LROM. Such loss of range of motion may, for example, be caused by traumatic injury, rehabilitation following joint or limb surgery, and contracture due to immobilization caused by neuromuscular disorders (e.g., stroke and closed head injury) and other disease processes that significantly limit a patient's ability to use a joint for normal activities of daily living (ADL).
Two fundamentally different types of contractures exist which clinically should have two different treatment protocols. The difference in these two types of contractures is the basis for the clinical techniques and design of the orthotics of the present invention which will be described below.
A first one of these two fundamentally different types of contracture may be defined as a fixed, high resistance of muscle to passive stretch resulting from fibrosis of the muscles and joints, or from disorders of the muscle fiber resulting in LROM, for example, of a patient's arm or leg. In this regard, Webster's Dictionary defines "contracture" as "a permanent shortening (as of muscle, tendon and scar tissue) producing deformity or distortion."
This first type of contracture is usually due to trauma, injury, or surgical intervention affecting the joint, as may be typical of sports injuries and the treatment thereof. As the injured tissue heals, edema, post trauma or surgically affected tissue regeneration and other natural healing processes result in fusing together of what were, prior to the trauma, separate, pristine connective tissues, that is, the collagen fiber matrix (depicted diagrammatically in FIG. 1A hereof), capable of easily gliding over one another, as is needed for normal joint movement and related muscle elongation.
However, post-trauma, this collagen fiber matrix becomes random and irregular (depicted diagrammatically in FIG. 1B hereof), and neither elongates nor stretches compared to non-traumatized collagen fibers. This fusing-together or adhesion of connective tissue structures (e.g., ligaments, tendons, synovial membrane, fascia and fibrous joint capsules) is the result of the tissues being invaded by developing undifferentiated scar between adjacent tissue, thereby diminishing or preventing the mutual gliding after early healing of the trauma or post-surgical trauma has been accomplished.
Such fusing together of connective tissue is a leading cause of lags (a non-specific indictment of the motor system's failure to move the affected joint through the full available passive range) relating to tendon gliding, depending on their strategic placement in reference to structures crossing the joint. With limited mobility and associated extensor muscle atrophy, combined with the formation of adhesions and scar tissue in the form of a significantly increased number of joined fiber matrix junctions, the muscle fibers become shortened.
The restoration of full range of motion where fibrosis of the muscle fiber with scar tissue and adhesions are present, requires that the adhesions and scar tissue or fused fiber matrix junctions be "worked through" or broken to restore normal functional elongation or stretch. The term "no pain, no gain" (of increased ROM) is associated with the process of breaking through joined or fused fiber matrix junctions to restore full elongation of the connective tissue, tendons and muscles associated with the trauma-affected joint.
Heretofore known orthotics are primarily designed to treat this first type of contracture, but have also been used to treat contractures caused by immobility and neurological dysfunction (described below). However, such orthotic devices are not, as far as is known by the present inventor, best suited for such additional purpose.
The second and very different type of contracture results from joint immobility--not joint-related trauma or surgical repair of a joint. Contracture resulting from immobility is simply a shortening and thickening of the connective tissue, tendons and muscles (depicted in FIG. 1C hereof) that restrict the ROM of a joint. In such situations, the muscle fibers still retain their original uniform shape and there are no adhesions or scar tissue or significantly increased joined fiber matrix junctions to break through in order to restore full range of motion.
In contrast to trauma-caused contractures, contractures due to immobility do not need a "no pain, no gain" approach to restoring the normal range of motion, and, in fact, such an approach can actually do more harm than good. As mentioned above, the collagen fibers of a contracture due to immobility are simply shorter and thicker, and will respond to appropriate stretching techniques and motion of the joint to restore LROM. The stretching technique usually used for contractures caused by immobility is Range Of Motion (ROM) Therapy and the use of Low-Load Protracted Stretch/Stress (LLPS) or "extended stretch" static or dynamic orthotic devices.
According to authors Kenneth R. Flowers and Susan L. Michlovitz in their article titled "ASSESSMENT AND MANAGEMENT OF LOSS OF MOTION IN ORTHOPEDIC DYSFUNCTION" (published in Postgraduate Advances in PHYSICAL THERAPY, American Physical Therapy Association, 1988 II-VIII), Total End Range Time (TERT) in conjunction with LLPS is the key to restoring full ROM.
All contractures, whether caused by injury, surgery, or immobility, limit range of motion of the affected joint and make simple activities of daily living, such as eating and self-dressing, more difficult, if not impossible. Moderate to severe contractures can be debilitating, and can leave afflicted individuals bed-bound and unable to care for themselves in the most basic daily living tasks. Even mild contractures due to immobility can progress to severe contractures if proper intervention is not prescribed and implemented so long as the immobility continues.
Electrotherapy has been used extensively in the rehabilitation of joint and muscle related injury, pain, and LROM. Electrotherapy also has demonstrated other valuable healing properties. Many forms of electrotherapy exist, and are characterized by the wave form of the electrical current. The wave form "rate" or frequency refers to the number of pulses delivered per second. Pulse rate is the number of pulses in each energy wave. Pulse width is the length of time each energy burst stays on (for example, double pulse width to double the energy in that pulse). Pulse amplitude or height of the pulse increases as the amplitude setting is increased. The total energy per pulse is determined by the amplitude and pulse width. Many variations of electrotherapy wave forms exist that are utilized therapeutically for joint rehabilitation, pain management, and the healing properties provided by electrical stimulation.
The use of transcultaneous electric neuromuscular stimulation or TENS has been used extensively to treat muscle injury and related pain. TENS is characterized by biphasic electric current and selected parameters. TENS has clinically demonstrated the ability to increase blood flow, reduce swelling and edema, and provide both acute and chronic pain relief. TENS is commonly used to treat back and cervical muscular and disc syndromes, arthritis, shoulder syndromes, neuropathies and many other conditions. Neuromuscular electrical stimulation or NMES also provides many therapeutic benefits. NMES is characterized by a low volt stimulation targeted at motor nerves to cause a muscle contraction. Electrically controlled contraction/relaxation of muscles has been found to effectively treat a variety of musculoskeletal and vascular conditions. It is used to maintain or increase range of motion, prevent or retard disuse atrophy, muscle re-education, relaxation of muscle spasm, increase circulation, and for deep vein thrombosis prevention.
Microcurrent therapy is characterized by a subsensory current that acts on the body's naturally occurring electrical impulses to decrease pain and facilitate the healing process. Such form of electrotherapy provides symptomatic pain relief for both post surgical and post traumatic acute pain. Interferntial therapy or IF is characterized by the crossing of two medium, independent frequencies which work together to effectively stimulate large impulse fibers. These frequencies interfere with the transmission of pain message at the spinal chord level. Because of these frequencies, the IF wave meets low impedance when crossing the skin to underlying tissue. This deep tissue penetration can be adjusted to stimulate parasympathetic nerve fibers for increased blood flow and edema reduction. High Voltage Galvanic Therapy is characterized by high volt, pulsed galvanic stimulation, and used primarily for local edema reduction through muscle pumping and through "polarity effect". This type of electrotherapy is used to increase or maintain range of motion, to treat disuse atrophy, for muscle re-education, to increase circulation, and to treat degenerative joint disease.
Different electrotherapy wave forms, for example, as described above, have been identified for the treatment of varying conditions. Some of the benefits are perceptible to the user (felt during therapy) and others are below the perception level. The specific electric pulse width and pulse rate can be controlled and varied, and as a result can have a wide range of clinical benefits. Electrotherapy can elicit very significant muscle contraction of specific muscles to entire muscle groups. On the opposite end of the spectrum, electrotherapy can be used to inhibit muscle contraction and even provide total nerve block therapy simply by directing the correct electrical wave form to the appropriate site to have the desired clinical effect. Electrotherapy has also been used to keep neurotransmitters in the muscles functioning normally until new neuropathways can be developed to reconnect the muscle groups to the brain post stroke, spinal cord injury, closed head injury, etc.
Electrotherapy has also been used to provide soft tissue therapy, and has been used extensively for the repair of nerves, tendons and ligaments as well as muscles. IF and electro-therapeutic applications have been used to treat contractures, re-connect damaged neuro-pathways, heal chronic wounds, and to treat incontinence. The U.S. Public Health Department in it's pamphlet on The Treatment of Pressure Sores cited electrotherapy has having the greatest clinical promise of providing possible treatment breakthroughs in the treatment of chronic wounds.
Electrotherapy is applied primarily through the use of an electrotherapy unit (device emitting a controlled electrical wave form and amplitude) through electrical connections to strategically placed electrodes placed on the body to provide electrical current to the desired site.
A principal objective of my current invention is accordingly to provide more clinically effective orthotics that are an alternative to the known types of orthotics currently used to treat contractures caused by immobility and the ROM stretching technique. The main function of my new and more effective orthotic devices is to treat contracture due to immobility--not trauma related to surgery or injury.
The present inventor considers that TERT with Activity Stimulus strategy (i.e., flexing)--not LLPS--is the key to predisposing tissue to elongation and restoring range of motion, where LROM is due to immobility or neurological dysfunction.
The clinical importance and value of my invention are significant in that contractures and other hazards of immobility are one of the ten current highest health care costs in America that are totally preventable. This puts the health risks associated with immobility in the same category as cigarette smoking, alcohol and drug abuse, and automobile accidents in financial impact on American health care costs.
The new orthotic devices of the present invention provide more effective clinical treatment for LROM due to immobility by increasing the "stimulus of activity" of the affected tissue (connective and muscle fiber) rather than just holding the issue in moderately lengthened position (LLPS or "gradual extension" therapy). According to Brand (1984), "It is better not to use the word stretch for what should be long-term growth. If we want to restore normal length to a tissue that has shortened after disease (or disuse), we need to reverse the process and apply the stimulus of activity, or better, the stimulus of holding the tissue in the moderately lengthened position for a significant time." According to Brand, it will then "grow" or lengthen. Flowers and Michovitz in the before-mentioned article theorize that the joint somehow senses or computes the total stress applied to it in any given direction over a period of time. It then stimulates a proportionate amount of biological activity, leading to a proportionate mount of remodeling of the stressed tissue. The total stress is a product of its intensity, frequency and duration. The crucial elements in this conceptual model are frequency and duration. Total stress equals intensity times frequency times duration (intensity.times.frequency.times.duration).
The present orthotic devices increase the stimulus of activity relative to current orthotic devices which simply hold the limb and joint in an extended position for extended periods. Conceptually, patient outcomes should be more positive based upon an increased stimulus of activity as well as providing moderate stretch for a prolonged period with the new devices. The cycling or repeated extension and contraction of the joint by the new devices provides the additional benefits of motion (activity), increased lubrication of the tissues (production of synovial fluid) facilitating movement, and muscle re-education and diminished spasticity where neurological dysfunction is present (stroke, closed head injury, MS, etc.). The level of activity is higher with the new devices when high tone, spasticity, or moderate to high contraction reflexes are present in the affected limb and joint. Thus the new devices are uniquely appropriate for contractures due to immobility where neurological dysfunction is present in the affected limb.